Interlaboratory comparison of 25-hydroxyvitamin D assays: Vitamin D Standardization Program (VDSP) Intercomparison Study 2 - Part 2 ligand binding assays - impact of 25-hydroxyvitamin D 2 and 24R,25-dihydroxyvitamin D 3 on assay performance.

Autor: Wise SA; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA. stephen.wise@nih.gov.; Scientist Emeritus, National Institute of Standards and Technology (NIST), MD, 20899, Gaithersburg, USA. stephen.wise@nih.gov., Camara JE; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Burdette CQ; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Hahm G; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Nalin F; Chemical Sciences Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, 20899, USA., Kuszak AJ; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA., Merkel J; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA., Durazo-Arvizu RA; Biostatistics Core, The Sabin Research Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, 90027, USA., Williams EL; Imperial Healthcare NHS Trust, London, W6 8RF, UK., Popp C; Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany., Beckert C; Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany., Schultess J; Abbott Laboratories, ADD Wiesbaden Abbott GmbH, 65205, Wiesbaden, Germany., Van Slooten G; Awareness Technology, Inc., Palm City, FL, 34990, USA., Tourneur C; bioMérieux, 69280, Marcy-l'Étoile, France., Pease C; bioMérieux, 69280, Marcy-l'Étoile, France., Kaul R; Clinical Diagnostics, Bio-Rad Laboratories, Hercules, CA, 94547, USA., Villarreal A; Clinical Diagnostics, Bio-Rad Laboratories, Hercules, CA, 94547, USA., Batista MC; Clinical Lab, Hospital Israelita Albert Einstein, São Paulo, 05652-900, Brazil., Pham H; Immunodiagnostic Systems (IDS), Boldon, NE35 9PD, UK., Bennett A; Immunodiagnostic Systems (IDS), Boldon, NE35 9PD, UK., Jansen E; National Institute of Public Health and the Environment (RIVM), 3720, Bilthoven, BA, Netherlands., Khan DA; National University of Medical Sciences (NUMS), Rawalpindi, 46000, Pakistan., Kilbane M; Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 T6F4, Ireland., Twomey PJ; Clinical Chemistry, St. Vincent's University Hospital, Elm Park, Dublin 4, D04 T6F4, Ireland., Freeman J; Siemens-Healthineers, Tarrytown, NY, 10591, USA., Parker N; Siemens-Healthineers, Tarrytown, NY, 10591, USA., Mushtaq S; University of Chester, Chester, CH1 4BJ, UK., Simpson C; School of Medicine, Yale University, New Haven, CT, USA., Lukas P; Clinical Chemistry, University of Liège, CHU de Liège, 4000, Liège, Belgium., Cavalier É; Clinical Chemistry, University of Liège, CHU de Liège, 4000, Liège, Belgium., Sempos CT; Office of Dietary Supplements (ODS), National Institutes of Health (NIH), Bethesda, MD, 20892, USA.; Vitamin D Standardization Program LLC, Havre de Grace, MD, 21078, USA.
Jazyk: angličtina
Zdroj: Analytical and bioanalytical chemistry [Anal Bioanal Chem] 2022 Jan; Vol. 414 (1), pp. 351-366. Date of Electronic Publication: 2021 Aug 25.
DOI: 10.1007/s00216-021-03577-0
Abstrakt: An interlaboratory comparison study was conducted by the Vitamin D Standardization Program (VDSP) to assess the performance of ligand binding assays (Part 2) for the determination of serum total 25-hydroxyvitamin D [25(OH)D]. Fifty single-donor samples were assigned target values for concentrations of 25-hydroxyvitamin D 2 [25(OH)D 2 ], 25-hydroxyvitamin D 3 [25(OH)D 3 ], 3-epi-25-hydroxyvitamin D 3 [3-epi-25(OH)D 3 ], and 24R,25-dihydroxyvitamin D 3 [24R,25(OH) 2 D 3 ] using isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS). VDSP Intercomparison Study 2 Part 2 includes results from 17 laboratories using 32 ligand binding assays. Assay performance was evaluated using mean % bias compared to the assigned target values and using linear regression analysis of the test assay mean results and the target values. Only 50% of the ligand binding assays achieved the VDSP criterion of mean % bias ≤ |± 5%|. For the 13 unique ligand binding assays evaluated in this study, only 4 assays were consistently within ± 5% mean bias and 4 assays were consistently outside ± 5% mean bias regardless of the laboratory performing the assay. Based on multivariable regression analysis using the concentrations of individual vitamin D metabolites in the 50 single-donor samples, most assays underestimate 25(OH)D 2 and several assays (Abbott, bioMérieux, DiaSorin, IDS-EIA, and IDS-iSYS) may have cross-reactivity from 24R,25(OH) 2 D 3 . The results of this interlaboratory study represent the most comprehensive comparison of 25(OH)D ligand binding assays published to date and is the only study to assess the impact of 24R,25(OH) 2 D 3 content using results from a reference measurement procedure.
(© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)
Databáze: MEDLINE
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